Masticatory muscle activity in normal individuals using two types of anterior deprogrammers – A Randomized Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Muscle activity of right and left Masseter and Temporalis using surface Electromyography
研究概览
简要总结
Clinical procedures:
Maxillary and mandibular impressions will be made for all the participants using Alginate impression material and the respective casts will be obtained. The casts will be articulated in maximal intercuspation on an articulator. Lucia Jig and Kois deprogrammer will be fabricated on the dental casts using self-cure acrylic material using standard protocols. Each participant will be allotted to the respective intervention groups as described previously.
Baseline activity of muscles (EMG) temporalis and masseter will be determined before insertion of the deprogrammers. Volunteers will be randomly given two types of deprogrammers - Lucia Jig and the Kois Deprogrammer. Deprogramming will be done for 30 minutes or till the time the volunteers give a precise centric point using an articulating paper.After deprogramming, the EMG activities of temporalis and masseter will be assessed again and recorded.
After a wash-out period of 1 week the volunteers will be allotted to the second intervention. Again, the volunteers’ base line muscle activity will be recorded, before the intervention. After insertion of the appliance, deprogramming will be done as described earlier and the muscle activities will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Healthy individuals 2.Male and female from age group of 18 years to 40 years.
- •3.Clinically symptom free for TMJ dysfunction (with Helkimo’s dysfunction index 0).
排除标准
- •1.Individuals under orthodontic treatment 2.TMJ or myofacial pain / Disorders 3.Patients with bruxism or other parafunctional habits.
结局指标
主要结局
Muscle activity of right and left Masseter and Temporalis using surface Electromyography
时间窗: Baseline (before insertion of appliance), 30 min after insertion of the appliance or after complete deprogramming is achieved - whichever is earlier
次要结局
- Pain/ discomfort in TMJ/ Muscles(30 min after insertion of appliance)
